SB 294, as amended, Emmerson. Sterile drug products.
(1) The Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. Existing law requires the board to adopt regulations establishing standards for compounding injectable sterile drug products in a pharmacy. Existing law requires pharmacies to obtain a license from the board, subject to annual renewal, in order to compound injectable sterile drug products. A similar licensing requirement applies to nonresident pharmacies compounding injectable sterile drug products for shipment into California. A violation of the Pharmacy Law is a crime.
This bill, commencing July 1, 2014, would expand these provisions to prohibit a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the board. The bill, commencing July 1, 2014, would specify requirements for the board for the issuance or renewal of a license, and requirements for the pharmacy as a licensee. The bill would require the board to adopt regulations to implement these provisions, as specified. By adding additional requirements to the Pharmacy Law concerning sterile drug products, the violation of which is a crime, the bill would impose a state-mandated local program.
(2) Existing law specifies the fee for issuance or renewal of a nongovernmental license to compound sterile drug products.
This bill, commencing July 1, 2014, would establish the fee for the issuance or renewal of a nonresident sterile compounding pharmacy license in the amount of $780 and would require the applicant to deposit a reasonable amount, as determined by the board, necessary to cover the board’s estimated cost of performing an inspection of the nonresident pharmacy location, as specified.
(3) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.
The people of the State of California do enact as follows:
The heading of Article 7.5 (commencing with
2Section 4127) of Chapter 9 of Division 2 of the Business and
3Professions Code is amended to read:
4
Section 4127 of the Business and Professions Code is
8amended to read:
(a) The board shall adopt regulations establishing
10standards for compounding injectable sterile drug products in a
11pharmacy.
12(b) The board shall adopt emergency regulations in accordance
13with the Administrative Procedure Act (Chapter 3.5 (commencing
14with Section 11340) of Part 1 of Division 3 of Title 2 of the
P3 1Government Code) to establish policies, guidelines, and procedures
2to initially implement the provisions of this article that become
3operative on July 1,begin delete 2014, including, but not limited to, building begin insert
2014.end insert The
4standards adopted pursuant to Part 2.5 (commencing with Section
518901) of Division 13 of the Health and Safety Code.end delete
6initial
adoption, amendment, or repeal of a regulation authorized
7by this section is deemed to address an emergency for purposes
8of Sections 11346.1 and 11346.6 of the Government Code, and
9the board is hereby exempted for that purpose from the
10requirements of subdivision (b) of Section 11346.1 of the
11Government Code. After the initial adoption, amendment, or repeal
12of an emergency regulation pursuant to this section, the board may
13request approval from the Office of Administrative Law to readopt
14the regulation as an emergency regulation pursuant to Section
1511346.1 of the Government Code.
16(c) This section shall become inoperative on July 1, 2014, and,
17as of January 1, 2015, is repealed, unless a later enacted statute,
18that becomes operative on or before January 1, 2015, deletes or
19extends the dates on which it becomes
inoperative and is repealed.
Section 4127 is added to the Business and Professions
21Code, to read:
(a) A pharmacy that compounds sterile drug products
23for injection, administration into the eye, or inhalation shall possess
24a sterile compounding pharmacy license as provided in this article.
25(b) The board shall adopt regulations in accordance with the
26Administrative Procedure Act (Chapter 3.5 (commencing with
27Section 11340) of Part 1 of Division 3 of Title 2 of the Government
28Code) to establish policies, guidelines, and procedures to
29implement thisbegin delete article, including, but not limited to, building begin insert
article.end insert
30standards adopted pursuant to Part 2.5 (commencing with Section
3118901) of Division 13 of the Health and Safety Code.end delete
32(c) This section shall become operative on July 1, 2014.
Section 4127.1 of the Business and Professions Code
34 is amended to read:
(a) A pharmacy shall not compound injectable sterile
36drug products in this state unless the pharmacy has obtained a
37license from the board pursuant to this section. The license shall
38be renewed annually and is not transferable.
39(b) A license to compound injectable sterile drug products may
40only be issued for a location that is licensed as a pharmacy.
P4 1Furthermore, the license to compound injectable sterile drug
2products may only be issued to the owner of the pharmacy license
3at that location. A license to compound injectable sterile drug
4products may not be issued until the location is inspected by the
5board and found in compliance with this article and regulations
6adopted by the
board.
7(c) A license to compound injectable sterile drug products may
8not be renewed until the location has been inspected by the board
9and found to be in compliance with this article and regulations
10adopted by the board.
11(d) Pharmacies operated by entities that are licensed by either
12the board or the State Department of Public Health and that have
13current accreditation from the Joint Commission on Accreditation
14of Healthcare Organizations, or other private accreditation agencies
15approved by the board, are exempt from the requirement to obtain
16a license pursuant to this section.
17(e) The reconstitution of a sterile powder shall not require a
18license pursuant to this section if both of the following are met:
19(1) The sterile powder was obtained from a manufacturer.
20(2) The drug is reconstituted for administration to patients by
21a health care professional licensed to administer drugs by injection
22pursuant to this division.
23(f) This section shall become inoperative on July 1, 2014, and,
24as of January 1, 2015, is repealed, unless a later enacted statute,
25that becomes operative on or before January 1, 2015, deletes or
26extends the dates on which it becomes inoperative and is repealed.
Section 4127.1 is added to the Business and Professions
28Code, to read:
(a) A pharmacy shall not compound sterile drug
30products unless the pharmacy has obtained a sterile compounding
31pharmacy license from the board pursuant to this section. The
32license shall be renewed annually and is not transferable.
33(b) A license to compound sterile drug products shall be issued
34only to a location that is licensed as a pharmacy and shall be issued
35only to the owner of the pharmacy licensed at that location.
36(c) A license to compound sterile drug products shall not be
37issued or renewed until the location is inspected by the board and
38found in compliance with this article and regulations adopted by
39
the board.
P5 1(d) A license to compound sterile drug products shall not be
2issued or renewed until the board does all of the following:
3(1) Reviews a current copy of the pharmacy’s policies and
4procedures for sterile compounding.
5(2) Reviews the pharmacy’s completed self-assessment form
6required by Section 1735.2 of Title 16 of the California Code of
7Regulations.
8(3) Is provided with copies of all inspection reports conducted
9of the pharmacy’s premises, and any reports from a private
10accrediting agency, conducted in the prior 12 months documenting
11the pharmacy’s operations.
12(4) Receives a list of all sterile medications compounded by the
13pharmacy since the last license renewal.
14(e) A pharmacy licensed pursuant to this section shall do all of
15the following:
16(1) Provide to the board a copy of any disciplinary or other
17action taken by another state within 10 days of the action.
18(2) Notify the board within 10 days of the suspension of any
19accreditation held by the pharmacy.
20(3) Provide to the board, within 12 hours, any recall notice
21issued by the pharmacy for sterile drug products it has
22compounded.
23(f) Adverse effects reported or potentially attributable to a
24pharmacy’s
sterile drug product shall be immediately reported to
25the board and the MedWatch program of the federal Food and
26Drug Administration.
27(g) The reconstitution of a sterile powder shall not require a
28license pursuant to this section if both of the following
29requirements are met:
30(1) The sterile powder was obtained from a manufacturer.
31(2) The drug is reconstituted for administration to patients by
32a health care professional licensed to administer drugs by injection
33pursuant to this division.
34(h) This section shall become operative on July 1, 2014.
Section 4127.2 of the Business and Professions Code
36 is amended to read:
(a) A nonresident pharmacy shall not compound
38injectable sterile drug products for shipment into the State of
39California without a license issued by the board pursuant to this
P6 1section. The license shall be renewed annually and shall not be
2transferable.
3(b) A license to compound injectable sterile drug products may
4only be issued for a location that is licensed as a nonresident
5pharmacy. Furthermore, the license to compound injectable sterile
6drug products may only be issued to the owner of the nonresident
7pharmacy license at that location. A license to compound injectable
8sterile drug products may not be issued or renewed until the board
9receives
the following from the nonresident pharmacy:
10(1) A copy of an inspection report issued by the pharmacy’s
11licensing agency, or a report from a private accrediting agency
12approved by the board, in the prior 12 months documenting the
13pharmacy’s compliance with board regulations regarding the
14compounding of injectable sterile drug products.
15(2) A copy of the nonresident pharmacy’s proposed policies
16and procedures for sterile compounding.
17(c) Nonresident pharmacies operated by entities that are licensed
18as a hospital, home health agency, or a skilled nursing facility and
19have current accreditation from the Joint Commission on
20Accreditation of Healthcare Organizations, or other private
21accreditation agencies approved by the board,
are exempt from
22the requirement to obtain a license pursuant to this section.
23(d) This section shall become inoperative on July 1, 2014, and,
24as of January 1, 2015, is repealed, unless a later enacted statute,
25that becomes operative on or before January 1, 2015, deletes or
26extends the dates on which it becomes inoperative and is repealed.
Section 4127.2 is added to the Business and Professions
28Code, to read:
(a) A nonresident pharmacy shall not compound sterile
30drug products for shipment into this state without a sterile
31compounding pharmacy license issued by the board pursuant to
32this section. The license shall be renewed annually and shall not
33be transferable.
34(b) A license to compound sterile drug products shall be issued
35only to a location that is licensed as a nonresident pharmacy and
36shall be issued only to the owner of the nonresident pharmacy
37licensed at that location.
38(c) A license to compound sterile drug products shall not be
39issued or renewed until the location is inspected by the board and
40found
in compliance with this article and any regulations adopted
P7 1by the board. The nonresident pharmacy shall reimburse the board
2for all actual and necessary costs incurred by the board in
3conducting an inspection of the pharmacy at least once annually
4pursuant to subdivision (v) of Section 4400.
5(d) A license to compound sterile drug products shall not be
6issued or renewed until the board does all of the following:
7(1) Reviews a current copy of the nonresident pharmacy’s
8policies and procedures for sterile compounding.
9(2) Reviews the pharmacy’s completed self-assessment form
10required by Section 1735.2 of Title 16 of the California Code of
11Regulations.
12(3) Is
provided with copies of all inspection reports conducted
13of the nonresident pharmacy’s premises, and any reports from a
14private accrediting agency, conducted in the prior 12 months
15documenting the nonresident pharmacy’s operations.
16(4) Receives a list of all sterile drug products compounded by
17the pharmacy within the prior 12 months.
18(e) A pharmacy licensed pursuant to this section shall do all of
19the following:
20(1) Provide to the board a copy of any disciplinary or other
21action taken by its state of residence or another state within 10
22days of the action.
23(2) Notify the board within 10 days of the suspension of any
24accreditation held by the pharmacy.
25(3) Provide to the board, within 12 hours, any recall notice
26issued by the pharmacy for sterile drug products it has compounded
27that have been shipped into, or dispensed in, California.
28(4) Advise the board of any complaint it receives from a
29provider, pharmacy, or patient in California.
30(f) Adverse effects reported or potentially attributable to a
31nonresident pharmacy’s sterile compounded drug product shall be
32immediately reported to the board and the MedWatch program of
33the federal Food and Drug Administration.
34(g) This section shall become operative on July 1, 2014.
Section 4400 of the Business and Professions Code is
36amended to read:
The amount of fees and penalties prescribed by this
38chapter, except as otherwise provided, is that fixed by the board
39according to the following schedule:
P8 1(a) The fee for a nongovernmental pharmacy license shall be
2four hundred dollars ($400) and may be increased to five hundred
3twenty dollars ($520). The fee for the issuance of a temporary
4nongovernmental pharmacy permit shall be two hundred fifty
5dollars ($250) and may be increased to three hundred twenty-five
6dollars ($325).
7(b) The fee for a nongovernmental pharmacy license annual
8renewal shall be two hundred fifty dollars ($250) and may be
9increased to three hundred twenty-five
dollars ($325).
10(c) The fee for the pharmacist application and examination shall
11be two hundred dollars ($200) and may be increased to two
12hundred sixty dollars ($260).
13(d) The fee for regrading an examination shall be ninety dollars
14($90) and may be increased to one hundred fifteen dollars ($115).
15If an error in grading is found and the applicant passes the
16examination, the regrading fee shall be refunded.
17(e) The fee for a pharmacist license and biennial renewal shall
18be one hundred fifty dollars ($150) and may be increased to one
19hundred ninety-five dollars ($195).
20(f) The fee for a nongovernmental wholesaler license and annual
21renewal shall be six hundred
dollars ($600), and may be increased
22to seven hundred eighty dollars ($780). The application fee for
23any additional location after licensure of the first 20 locations shall
24be two hundred twenty-five dollars ($225) and may be increased
25to three hundred dollars ($300). A temporary license fee shall be
26five hundred fifty dollars ($550) and may be increased to seven
27hundred fifteen dollars ($715).
28(g) The fee for a hypodermic license and renewal shall be one
29hundred twenty-five dollars ($125) and may be increased to one
30hundred sixty-five dollars ($165).
31(h) (1) The fee for application, investigation, and issuance of
32license as a designated representative pursuant to Section 4053
33shall be two hundred fifty-five dollars ($255) and may be increased
34to three
hundred thirty dollars ($330).
35(2) The fee for the annual renewal of a license as a designated
36representative shall be one hundred fifty dollars ($150) and may
37be increased to one hundred ninety-five dollars ($195).
38(i) (1) The fee for the application, investigation, and issuance
39of a license as a designated representative for a veterinary
40food-animal drug retailer pursuant to Section 4053 shall be two
P9 1hundred fifty-five dollars ($255) and may be increased to three
2hundred thirty dollars ($330).
3(2) The fee for the annual renewal of a license as a designated
4representative for a veterinary food-animal drug retailer shall be
5one hundred fifty dollars ($150) and may be increased to one
6hundred
ninety-five dollars ($195).
7(j) (1) The application fee for a nonresident wholesaler’s license
8issued pursuant to Section 4161 shall be six hundred dollars ($600)
9and may be increased to seven hundred eighty dollars ($780).
10(2) For nonresident wholesalers who have 21 or more facilities
11operating nationwide the application fees for the first 20 locations
12shall be six hundred dollars ($600) and may be increased to seven
13hundred eighty dollars ($780). The application fee for any
14additional location after licensure of the first 20 locations shall be
15two hundred twenty-five dollars ($225) and may be increased to
16three hundred dollars ($300). A temporary license fee shall be five
17hundred fifty dollars ($550) and may be increased to seven hundred
18fifteen dollars ($715).
19(3) The annual renewal fee for a nonresident wholesaler’s license
20issued pursuant to Section 4161 shall be six hundred dollars ($600)
21and may be increased to seven hundred eighty dollars ($780).
22(k) The fee for evaluation of continuing education courses for
23accreditation shall be set by the board at an amount not to exceed
24forty dollars ($40) per course hour.
25(l) The fee for an intern pharmacist license shall be ninety dollars
26($90) and may be increased to one hundred fifteen dollars ($115).
27The fee for transfer of intern hours or verification of licensure to
28another state shall be twenty-five dollars ($25) and may be
29increased to thirty dollars ($30).
30(m) The
board may waive or refund the additional fee for the
31issuance of a license where the license is issued less than 45 days
32before the next regular renewal date.
33(n) The fee for the reissuance of any license, or renewal thereof,
34that has been lost or destroyed or reissued due to a name change
35shall be thirty-five dollars ($35) and may be increased to forty-five
36dollars ($45).
37(o) The fee for the reissuance of any license, or renewal thereof,
38
that must be reissued because of a change in the information, shall
39be one hundred dollars ($100) and may be increased to one hundred
40thirty dollars ($130).
P10 1(p) It is the intent of the Legislature that, in setting fees pursuant
2to this section, the board shall seek to maintain a reserve in the
3Pharmacy Board Contingent Fund equal to approximately one
4year’s operating expenditures.
5(q) The fee for any applicant for a nongovernmental clinic
6license shall be four hundred dollars ($400) and may be increased
7to five hundred twenty dollars ($520) for each license. The annual
8fee for renewal of the license shall be two hundred fifty dollars
9($250) and may be increased to three hundred twenty-five dollars
10($325) for each license.
11(r) The fee for the issuance of a pharmacy technician license
12shall be eighty dollars ($80) and may be increased to one hundred
13five dollars ($105). The fee for renewal of a pharmacy technician
14license shall be one hundred dollars ($100) and may be increased
15to one hundred thirty dollars ($130).
16(s) The fee for a veterinary food-animal drug retailer license
17shall be four hundred five dollars ($405) and may be increased to
18four hundred twenty-five dollars ($425). The annual renewal fee
19for a veterinary food-animal drug retailer license shall be two
20hundred fifty dollars ($250) and may be increased to three hundred
21twenty-five dollars ($325).
22(t) The fee for issuance of a retired license pursuant to Section
234200.5 shall be thirty-five dollars ($35) and may be increased to
24forty-five
dollars ($45).
25(u) The fee for issuance or renewal of a nongovernmental license
26to compound sterile drug products shall be six hundred dollars
27($600) and may be increased to seven hundred eighty dollars
28($780). The fee for a temporary license shall be five hundred fifty
29dollars ($550) and may be increased to seven hundred fifteen
30dollars ($715).
31(v) This section shall become inoperative on July 1, 2014, and,
32as of January 1, 2015, is repealed, unless a later enacted statute,
33that becomes operative on or before January 1, 2015, deletes or
34extends the dates on which it becomes inoperative and is repealed.
Section 4400 is added to the Business and Professions
36Code, to read:
The amount of fees and penalties prescribed by this
38chapter, except as otherwise provided, is that fixed by the board
39according to the following schedule:
P11 1(a) The fee for a nongovernmental pharmacy license shall be
2four hundred dollars ($400) and may be increased to five hundred
3twenty dollars ($520). The fee for the issuance of a temporary
4nongovernmental pharmacy permit shall be two hundred fifty
5dollars ($250) and may be increased to three hundred twenty-five
6dollars ($325).
7(b) The fee for a nongovernmental pharmacy license annual
8renewal shall be two hundred fifty dollars ($250) and may be
9increased to three
hundred twenty-five dollars ($325).
10(c) The fee for the pharmacist application and examination shall
11be two hundred dollars ($200) and may be increased to two
12hundred sixty dollars ($260).
13(d) The fee for regrading an examination shall be ninety dollars
14($90) and may be increased to one hundred fifteen dollars ($115).
15If an error in grading is found and the applicant passes the
16examination, the regrading fee shall be refunded.
17(e) The fee for a pharmacist license and biennial renewal shall
18be one hundred fifty dollars ($150) and may be increased to one
19hundred ninety-five dollars ($195).
20(f) The fee for a nongovernmental wholesaler license and annual
21renewal
shall be six hundred dollars ($600), and may be increased
22to seven hundred eighty dollars ($780). The application fee for
23any additional location after licensure of the first 20 locations shall
24be two hundred twenty-five dollars ($225) and may be increased
25to three hundred dollars ($300). A temporary license fee shall be
26five hundred fifty dollars ($550) and may be increased to seven
27hundred fifteen dollars ($715).
28(g) The fee for a hypodermic license and renewal shall be one
29hundred twenty-five dollars ($125) and may be increased to one
30hundred sixty-five dollars ($165).
31(h) (1) The fee for application, investigation, and issuance of
32license as a designated representative pursuant to Section 4053
33shall be two hundred fifty-five dollars ($255) and may be increased
34to
three hundred thirty dollars ($330).
35(2) The fee for the annual renewal of a license as a designated
36representative shall be one hundred fifty dollars ($150) and may
37be increased to one hundred ninety-five dollars ($195).
38(i) (1) The fee for the application, investigation, and issuance
39of a license as a designated representative for a veterinary
40food-animal drug retailer pursuant to Section 4053 shall be two
P12 1hundred fifty-five dollars ($255) and may be increased to three
2hundred thirty dollars ($330).
3(2) The fee for the annual renewal of a license as a designated
4representative for a veterinary food-animal drug retailer shall be
5one hundred fifty dollars ($150) and may be increased to one
6hundred
ninety-five dollars ($195).
7(j) (1) The application fee for a nonresident wholesaler’s license
8issued pursuant to Section 4161 shall be six hundred dollars ($600)
9and may be increased to seven hundred eighty dollars ($780).
10(2) For nonresident wholesalers who have 21 or more facilities
11operating nationwide the application fees for the first 20 locations
12shall be six hundred dollars ($600) and may be increased to seven
13hundred eighty dollars ($780). The application fee for any
14additional location after licensure of the first 20 locations shall be
15two hundred twenty-five dollars ($225) and may be increased to
16three hundred dollars ($300). A temporary license fee shall be five
17hundred fifty dollars ($550) and may be increased to seven hundred
18fifteen dollars ($715).
19(3) The annual renewal fee for a nonresident wholesaler’s license
20issued pursuant to Section 4161 shall be six hundred dollars ($600)
21and may be increased to seven hundred eighty dollars ($780).
22(k) The fee for evaluation of continuing education courses for
23accreditation shall be set by the board at an amount not to exceed
24forty dollars ($40) per course hour.
25(l) The fee for an intern pharmacist license shall be ninety dollars
26($90) and may be increased to one hundred fifteen dollars ($115).
27The fee for transfer of intern hours or verification of licensure to
28another state shall be twenty-five dollars ($25) and may be
29increased to thirty dollars ($30).
30(m) The
board may waive or refund the additional fee for the
31issuance of a license where the license is issued less than 45 days
32before the next regular renewal date.
33(n) The fee for the reissuance of any license, or renewal thereof,
34that has been lost or destroyed or reissued due to a name change
35shall be thirty-five dollars ($35) and may be increased to forty-five
36dollars ($45).
37(o) The fee for the reissuance of any license, or renewal thereof,
38that must be reissued because of a change in the information, shall
39be one hundred dollars ($100) and may be increased to one hundred
40thirty dollars ($130).
P13 1(p) It is the intent of the Legislature that, in setting fees pursuant
2to this section, the board shall seek to maintain a reserve
in the
3Pharmacy Board Contingent Fund equal to approximately one
4year’s operating expenditures.
5(q) The fee for any applicant for a nongovernmental clinic
6license shall be four hundred dollars ($400) and may be increased
7to five hundred twenty dollars ($520) for each license. The annual
8fee for renewal of the license shall be two hundred fifty dollars
9($250) and may be increased to three hundred twenty-five dollars
10($325) for each license.
11(r) The fee for the issuance of a pharmacy technician license
12shall be eighty dollars ($80) and may be increased to one hundred
13five dollars ($105). The fee for renewal of a pharmacy technician
14license shall be one hundred dollars ($100) and may be increased
15to one hundred thirty dollars ($130).
16(s) The fee for a veterinary food-animal drug retailer license
17shall be four hundred five dollars ($405) and may be increased to
18four hundred twenty-five dollars ($425). The annual renewal fee
19for a veterinary food-animal drug retailer license shall be two
20hundred fifty dollars ($250) and may be increased to three hundred
21twenty-five dollars ($325).
22(t) The fee for issuance of a retired license pursuant to Section
234200.5 shall be thirty-five dollars ($35) and may be increased to
24forty-five dollars ($45).
25(u) The fee for issuance or renewal of a nongovernmental sterile
26compounding pharmacy license shall be six hundred dollars ($600)
27and may be increased to seven hundred eighty dollars ($780). The
28fee for a temporary license shall be five hundred fifty dollars ($550)
29and
may be increased to seven hundred fifteen dollars ($715).
30(v) The fee for the issuance or renewal of a nonresident sterile
31compounding pharmacy license shall be seven hundred eighty
32dollars ($780). In addition to paying that application fee, the
33nonresident sterile compounding pharmacy shall deposit, when
34submitting the application, a reasonable amount, as determined by
35the board, necessary to cover the board’s estimated cost of
36performing the inspection required by Section 4127.2. If the
37required deposit is not submitted with the application, the
38application shall be deemed to be incomplete. If the actual cost of
39the inspection exceeds the amount deposited, the board shall
40provide to the applicant a written invoice for the remaining amount
P14 1and shall not take action on the application until the full amount
2has been paid to the board. If the
amount deposited exceeds the
3amount of actual and necessary costs incurred, the board shall
4remit the difference to the applicant.
5(w) This section shall become operative on July 1, 2014.
No reimbursement is required by this act pursuant to
7Section 6 of Article XIII B of the California Constitution because
8the only costs that may be incurred by a local agency or school
9district will be incurred because this act creates a new crime or
10infraction, eliminates a crime or infraction, or changes the penalty
11for a crime or infraction, within the meaning of Section 17556 of
12the Government Code, or changes the definition of a crime within
13the meaning of Section 6 of Article XIII B of the California
14Constitution.
O
95